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Minimally Invasive Endoscopic Treatment of Zenker's Diverticulum Comparing LigaSureTM vs SB-Knife.

NCT04660214 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-02-23

No results posted yet for this study

Summary

The main purpose of this trial is to evaluate two devices used in the treatment of Zenker Diverticulum using flexible endoscopy (LigaSure and SB-knife). Analyze the technical success, clinical success, relapses, complications, and the mean procedure time with each device prospectively in order to transfer objective and uniform results to routine clinical practice.

Conditions

  • Zenker Diverticulum
  • Minimally Invasive Surgical Procedures
  • Endoscopy

Interventions

DEVICE

septotomy

endoscopic diverticulotomy

Sponsors & Collaborators

  • Hospital del Rio Hortega

    lead OTHER

Principal Investigators

  • Mª Henar Núñez-Rodriguez, MD PhD · Gastroenterology Department, Hospital Rio Hortega

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2024-06-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04660214 on ClinicalTrials.gov